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MB-CART19.1
MB-CART19.1 is a Biologic drug developed by Miltenyi Biomedicine GmbH. It is currently in Phase 2 development. Also known as: CD19-targeting CAR T cells, Anti-CD19 CAR T cells, Miltenyi CD-19 CAT-T cell.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | MB-CART19.1 |
|---|---|
| Also known as | CD19-targeting CAR T cells, Anti-CD19 CAR T cells, Miltenyi CD-19 CAT-T cell |
| Sponsor | Miltenyi Biomedicine GmbH |
| Modality | Biologic |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- MB-CART19.1 in Relapsed/Refractory Acute Lymphoblastic Leukemia (NA)
- A Study of MB-CART19.1 Cellular Therapy for People With Central Nervous System Lymphoma (CNSL) (PHASE1)
- Study of CART Cell (MB-CART19.1) in Patients With Relapsed or Refractory CD19 Positive NHL (PHASE2)
- Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies (NA)
- MB-CART19.1 in Refractory SLE (PHASE1, PHASE2)
- MB-CART19.1 r/r CD19+ B-cell Malignancies (BCM) (PHASE1)
- MB-CART19.1 in Patients With R/R ALL (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- MB-CART19.1 CI brief — competitive landscape report
- MB-CART19.1 updates RSS · CI watch RSS
- Miltenyi Biomedicine GmbH portfolio CI
Frequently asked questions about MB-CART19.1
What is MB-CART19.1?
Who makes MB-CART19.1?
Is MB-CART19.1 also known as anything else?
What development phase is MB-CART19.1 in?
Related
- Manufacturer: Miltenyi Biomedicine GmbH — full pipeline
- Also known as: CD19-targeting CAR T cells, Anti-CD19 CAR T cells, Miltenyi CD-19 CAT-T cell
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing